BEUDAMED
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    SPIROMETER FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EZSLEEP SLEEP QUALITY RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REALSEAL

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·May 15, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    NITINOL GUIDEWIRE WI/FLOPPY PLATINUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code DYB·August 24, 2010

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013